A Safety and Efficacy Study of XP19986 in Subjects With Spasticity Due to Spinal Cord Injury

This study has been completed.

Sponsor:

Indivior Inc.

ClinicalTrials.gov Identifier:

NCT00557973

First Posted: November 14, 2007

Last Update Posted: September 23, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Ashworth score for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose. Evaluate the difference in the primary endpoint between active and placebo treament segments at 17th day of dosing in each segment

Secondary Outcome Measures:

Average Ashworth score [ Time Frame: Day 17 ]

This was the average of Ashworth scores obtained on Day 17 of dosing across 6 muscle groups for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose

Two Highest Ashworth scores [ Time Frame: Day 17 ]

This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had the 2 highest Ashworth scores at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose

Average Non-zero Ashworth Scores [ Time Frame: Day 17 ]

This was the average of Ashworth scores obtained on Day 17 of dosing from the muscle groups that had a non-zero Ashworth score at baseline for each treatment segment before dosing and 2, 4, and 6 hours after the morning dose

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 10 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 10 mg BID

XP19986 Sustained Release (SR) 10 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Other Name: Sustained release Polyox WSR N750, 10 mg

Drug: Placebo

Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.

Other Name: sugar pill

Experimental: XP19986 SR1 20 mg - Placebo

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 20 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 20 mg BID

XP19986 Sustained Release (SR) 20 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Other Name: Sustained release Polyox WSR N750, 20 mg

Drug: Placebo

Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.

Other Name: sugar pill

Experimental: XP19986 SR1 30 mg - Placebo

Following a 7 day run-in period in which participants take placebo twice a day (BID), participants are randomized to the cohort that will take XP19986 SR1 30 mg BID treatment crossing over to placebo treatment (or the reverse order). Each treatment segment follows the same pattern: 3-9 days of titration, 7 days at target dose, 3-9 days of tapering, followed by a 3-day placebo washout.

Drug: XP19986 SR1, 30 mg BID

XP19986 Sustained Release (SR) 30 mg tablet dosed orally, twice a day (BID), for approximately 26 days with titration and taper periods

Other Name: Sustained release Polyox WSR N750, 30 mg

Drug: Placebo

Placebo tablets to match active intervention, taken twice a day (BID) for approximately 26 days with titration and taper periods. Also taken during placebo washout periods.

Other Name: sugar pill

Detailed Description:

This is a multiple-dose, randomized, placebo-controlled crossover study of the efficacy and safety of XP19986 SR1 in subjects with spasticity due to spinal cord injury. Three cohorts of subjects are randomized to receive XP19986 SR1 10 mg every 12 hrs or 20 mg every 12 hrs or 30 mg every 12 hrs in one treatment segment and placebo every 12 hrs in the alternate treatment segment. Each subject serves as their own control in this cross-over study.

Eligibility

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